Kornimate/medical-research-clean huggingface dataset:
equivalence of a human-powered nebulizer to an electric nebulizer

Conditions: Asthma

Summary: this is an equivalence study comparing an electric nebulizer with a human-powered nebulizer--one that does not need electricity--in the treatment of mild to moderate asthma exacerbations in a regional clinic in san salvador, el salvador.

the study design is to treat individuals suffering from mild to moderate exacerbations of asthma with nebulized salbutamol (2.5mg). subjects will receive nebulization using either an electric nebulizer compressor or a human-powered nebulizer compressor. improvement in peak expiratory flow will be the primary endpoint. blood oxygenation levels as measured by pulse oximetry will be a secondary endpoint of the trial.

Eligibility criteria:
inclusion criteria: * suffering from mild or moderate asthma symptoms * increased respiratory rate, but not over 30 breaths per minute * reduced peak expiratory flow rate, but not less than 60% of normal * oxygen saturation levels reduced but greater than 90% exclusion criteria: * any other respiratory condition that would interfere with nebulizer treatment * if any other medication is being taken at the time * pregnant women or women who may think they might be pregnant * never taken salbutamol before

Keywords: asthma nebulizers salbutamol developing countries
garadacimab safety, pharmacokinetics, and pharmacodynamics in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of garadacimab in subjects with idiopathic pulmonary fibrosis (ipf).


Eligibility criteria:
inclusion criteria: * male or female patients ≥ 40 years of age * documented diagnosis of ipf exclusion criteria: * history of clinically significant cardiovascular disease, including myocardial infarction, unstable ischemic heart disease, congestive heart failure, or angina during the 6 months before screening * sinoatrial or atrioventricular block, uncontrolled hypertension * active bleeding or current clinically significant coagulopathy
treatment of anorexia nervosa in children and adolescents: an integrated family based and metacognitive approach

Conditions: Anorexia Nervosa

Summary: the goal of this study is to evaluate the treatment effects of an integrated treatment called family-based and metacognitive therapy for patients with anorexia nervosa. in addition, we will evaluate if an active follow-up of the patients will reduce the number of relapses, which is common during the 1 year after discharge. fifty patients aged 12-18 years old and their parents will be invited to participate in this study and all will receive the same treatment but be randomly allocated to different follow-up conditions. the active follow-up includes 3 sessions of metacognitive therapy and the passive follow-up includes ordinary follow-up, with no booster sessions. the patients will be assessed at baseline, pre-treatment, post-treatment, and at 6 and 12 months follow-up.

the study is an evaluation of a new approach to treating anorexia nervosa (f.50.0 and f 50.1) called family-based and metacognitive therapy. the treatment integrates both family-based work approach, where the parents learn to be in control of the meal situation and communicate better with their child. the metacognitive treatment approach, is targeting the child to work with its problems with emotional regulation and self-esteem issues, but also their attitudes to body and weight. our aim is to both address what the overall effect of the treatment will be, but also to test if an active follow-up after discharge will lead to reduced relapse rates in the 12 months after treatment. we will apply the same approach to all included patients (a-b design), but the patients and their parents will be allocated to one of two different conditions for follow-up. the active follow-up involves receiving 3 sessions of metacognitive therapy, whereas the other group gets ordinary follow-up, with no sessions of mct. all patients are assessed at baseline, pre-treatment, post-treatment, and by 6 and 12 months follow-up. the purpose of the design is to evaluate if the rate of relapse during the first year after discharge can be reduced

Eligibility criteria:
inclusion criteria: * primary diagnosis of f 50.0 and f 50.1 exclusion criteria: * psychotic symptoms * severe somatic illness * mental retardation or developmental disorder * bipolar disorder * extreme self-mutilation or acute suicidal risks * does not speak or understand norwegian
a study to investigate the efficacy, and safety of the colovac colorectal anastomosis protection device.

Conditions: Gastrointestinal Anastomotic Complication

Summary: the purpose of this study is to evaluate thecolovac device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).


Eligibility criteria:
inclusion criteria: 1. subject must be \>= 18 and \<= 65 years old 2. indicated for colorectal resection 3. patient has been assessed by a multi-disciplinary team and it was determined that as per standard of care, they are eligible to bear a diverting ostomy 4. willing to comply with protocol-specified follow-up evaluations 5. signed informed consent exclusion criteria: 1. patient with inflammatory bowel disease 2. pregnant or nursing female subject (a pregnancy test should be conducted the day prior to the procedure for all women in age of procreating) 3. known allergy to nickel or other components of the colovac kit 4. any significant medical condition which, in the investigator's opinion, may interfere with the subject's optimal participation in the study, including: 1. immunodeficiency 2. steroid therapy 3. infections at the time of intervention 4. major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study 5. diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis 6. preexisting sphincter problems or evidence of extensive local disease in the pelvis 7. blood loss (\> 500 cc) 8. non amended peroperative anastomosis failure 9. intra-operative adverse events 10. malnourishment 11. obesity (bmi \> 35) 12. history of excessive smoking and alcohol use 5. the subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study 6. patient unable to give consent

Keywords: anastomotic leakage fistula
muscle fatigue and carbonic anhydrase inhibitors

Conditions: Hypoxia

Summary: the objective of this research is to assess the effects of acetazolamide and methazolamide on respiratory and limb muscle fatigue development. a fatiguing protocol will be conducted for the respiratory and plantar flexor muscles and the difference in pressure/torque produced by supramaximal nerve stimulation used to assess muscle fatigue between conditions.


Eligibility criteria:
inclusion criteria: * age: 18-40 years. * regularly physically active * male exclusion criteria: * current or ex-smokers * pulmonary function \<80% of predicted * esophageal tumour or ulcer * have had recent (\<6 months) musculoskeletal injury or any surgery to the lower leg * have contraindications to carbonic anhydrase inhibitors (eg. severe or absolute glaucoma, adrenocortical insufficiency, hepatic insufficiency, renal insufficiency, sulfa allergy or an electrolyte imbalance such as hyperchloremic acidosis) * are obese (bmi \>30 kg/m2) * taking diuretics, blood thinners, or anti-platelet drugs.

Keywords: muscle fatigue acetazolamide methazolamide
efficacy, safety and pharmacokinetics of bcd-100 (anti-pd-1) monotherapy as second line treatment in patients with non-small cell lung cancer (dominus)

Conditions: Non Small Cell Lung Cancer Stage IIIB; Non-Small Cell Carcinoma of Lung, TNM Stage 4

Summary: international multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of bcd-100 (jsc biocad, russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced inoperable or metastatic non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * verified diagnosis of non-small cell lung cancer * verified progression of the disease after or during first-line chemotherapy based on platinum drugs * absence of mutation of egfr and alk genes * ecog score 0-1 * at least one lesion, that is measurable according to recist 1.1 criteria * absence of severe organ pathology * anticipated live duration more that 12 weeks after screening * brain metastases with clinical symptoms requiring glucocorticoids and/or anticonvulsant drugs exclusion criteria: * egfr and/or alk mutations * patients with severe of live-threatening acute complications of the disease * intersticial lung diseases or pneumonitis * concomitant diseases that affect safety evaluation * autoimmune diseases * endocrine diseases that could not be compensated by hormonal therapy * patient needs glucocorticoids * significant liver or renal diseases * lactate dehydrogenase exceeds upper limit of normal more that 2-fold * more that 1 chemotherapy lines for advanced/metastatic non-small cell lung cancer treatment * anti-tumor treatment ending less then 28 days before screening * prior therapy with anti-ctla4 and/or anti-pd-1/pd-l1/pd-l2 drugs * prior therapy with docetaxel * concomitant oncological diseases except treated cervical carcinoma in situ or radically resected squamous-cell carcinoma * allergy to drugs based on monoclonal antibodies or docetaxel or polysorbate 80, severe reactions to paclitaxel * pregnancy and lactation
safety and efficacy of umbilical cord-derived mesenchymal stem cell(msc) transplantation in the treatment of bronchopulmonary dysplasia(bpd) in premature infants

Conditions: BPD - Bronchopulmonary Dysplasia

Summary: bronchopulmonary dysplasia (bpd) is a chronic lung disease, which is a major complication of very low and ultra-low preterm infants. moderate and severe bpd survivors are prone to adverse outcomes such as impaired lung function, childhood exercise intolerance, and neurodevelopmental retardation in the long term, which seriously affects their quality of life and brings a heavy burden to society and families. however, the pathogenesis of bpd is complex, including pulmonary vascular dysplasia, lung inflammation, and impaired alveolar development. there is currently no specific clinical drug to cure bpd. mesenchymal stem cells (mscs) are a kind of multipotent stem cells that exist in almost all organs and tissues of individuals. mscs have the properties including self-renewal, multi-directional differentiation, and immunosuppressive and anti-inflammatory abilities. preclinical studies have shown that mscs can alleviate bpd by improving alveolar and pulmonary vascular development, and reducing pulmonary fibrosis. several phase i clinical studies have demonstrated that intratracheal transplantation of human umbilical cord blood-derived mesenchymal stem cells for children with bpd is safe and feasible. this study aims to further evaluate the safety and efficacy of umbilical cord-derived mesenchymal stem cell transplantation in the treatment of severe bpd in premature infants, in the hope of increasing the survival rate and improving the prognosis of severe bpd.


Eligibility criteria:
inclusion criteria: 1. 23-29 weeks of gestation, birth weight 500-1500g; 2. for patients with no improvement or aggravation of lung condition after dart hormone therapy, and positive pressure ventilation by tracheal intubation is still required at a correct gestational age of 36 weeks. 3. children with severe bpd after early use of ps 4. parents agree to participate in clinical trials. exclusion criteria: 1. premature infants not suitable for the given gestational age; 2. other congenital structural malformations of trachea, bronchus and lungs; 3. complicated with severe congenital heart disease; 4. complicated with periventricular leukomalacia (pvl); 5. complicated with intraventricular hemorrhage (ivh) above level 3; 6. septic shock or positive blood culture; 7. acute pulmonary hemorrhage; 8. intracranial and extracranial diseases affecting respiratory rate and rhythm.

Keywords: bronchopulmonary dysplasia (bpd) mesenchymal stem cells (mscs) premature infants
impact of predialytic oral protein on nutritional status and quality of life in hd patients

Conditions: Hemodialysis Complication

Summary: the aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients

chronic kidney disease (ckd) is a prevalent chronic condition and the incidence of end-stage renal disease (esrd) is expected to increase over the next few decades. in patients with ckd, especially in those with esrd and undergoing maintenance dialysis therapy (mdt), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (pew), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of ckd . oral nutritional supplement (ons) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ons) when appropriate.

Eligibility criteria:
inclusion criteria: * adult hemodialysis patients (≥18 years of age). * received dialysis for at least 6 months prior to study screening. * receive hemodialysis at least 3 times per week . exclusion criteria: * receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study . * participants with an allergy to any ingredients in the nutritional supplements. * persistent hyperkalemia or hyperphosphatemia (defined as the last 3 months). * significant edema and fluid overload. * hepatic patients

Keywords: oral protein protein supplementation hemodialysis quality of life
a study of local effect and safety of a single ppc-5650 dose on reflux pain during pain stimulation in the esophagus

Conditions: Gastroesophageal Reflux; Gastroesophageal Reflux Disease

Summary: the purpose of this trial is to evaluate the effect of a single ppc-5650 dose in a human pain model including multimodal (mechanical, thermal, electrical, chemical) stimulations of the esophagus.


Eligibility criteria:
inclusion criteria: * signed informed consent before any study specific procedures * able to read and understand danish. * healthy i.e. no history of chronic or recurrent pain rewarding diseases * able to co-operate and tolerate the experimental procedures (as assessed in the training visit) * no over the counter medication 24h before the three visits * no medications in the study period * bmi 18.5-35.0 * caucasian * no symptoms of gastroesophageal reflux disease * all men must use a safe method of contraception during the study period exclusion criteria: * any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, and/or urine analyses, as judged by the investigator. * participation in any other clinical trial within three months prior to the training day. * alcohol or drug abuse. * mental illnesses * allergic to the active ingredient in the investigational medicinal product

Keywords: gastroesophageal reflux
design of an intervention to equip middle managers and managers in healthcare institutions with tools to increase the resilience of their teams

Conditions: Occupational Health; Resilience; Job Stress; Well-being At Work; Highly Stressful Situations; Healthcare Worker

Summary: the main objective of this preparatory action (experimental study without control group, before and after measurements) is to develop and test the feasibility of the e-resilience tool in a relevant environment (trl6). this web-based tool has been designed to facilitate the work of the top and middle management of healthcare institutions to strengthen the resilience of their teams to face critical situations inherent to healthcare activity. the main questions it aims to answer are: 1. which components of the e-resilience intervention need to be improved? 2. does the e-resilience tool improve the knowledge of middle managers in healthcare institutions on specific techniques and strategies to strengthen the resilience of the professionals and teams under their care? 3. is the e-resilience tool helpful and applicable to clinical settings in the opinion of middle managers in healthcare institutions? participants in the study are middle management and healthcare professionals from primary care centres and hospitals in the valencian community (spain). a group of experts review the components of the intervention/tool to improve its adaptability to clinical settings. subsequently, a sample of healthcare professionals and middle managers complete the intervention by answering a knowledge questionnaire before and after the intervention and a survey to evaluate the tool. there is no control group.


Eligibility criteria:
inclusion criteria: * healthcare professionals and middle management in active healthcare institutions. exclusion criteria: * inability to complete the web-based intervention due to access difficulties or lack of digital literacy.
intracerebral hemorrhage due to oral anticoagulants: prediction of the risk by magnetic resonance

Conditions: Ischemic Stroke

Summary: the purpose of this study is to determine whether magnetic resonance imaging may predict the risk of intracerebral hemorrhage for patients with ischemic stroke who receive indefinite oral anticoagulation

objectives. to evaluate whether magnetic resonance (mr) helps in predicting the risk of intracranial hemorrhage (ich-oa) in patients with ischemic stroke who will receive oral anticoagulants (oa) for the secondary prevention of stroke. by allowing the detection and quantification of leukoaraiosis and microbleeding, mr aids in the assessment of hypertensive and/or amyloid angiopathy, two findings that may increase the risk of ich-oa. the study of these and other known variables associated with the risk of ich-oa will improve the selection of patients to be treated with oa. methodology. a prospective, observational, multicentric study of 1000 patients with stroke, older than 65 y, candidates to receive oa indefinitely. the primary end-point is ich-oa. a mr will be performed before starting the treatment, in which we will evaluate the presence and degree of leukoaraiosis (fazekas's scale) and microbleeding (bombs scale). a visit will be scheduled at the first month after inclusion, and thereafter the patient will be followed-up during 2 years with phone interviews, to evaluate the appearance of the primary end-point. we will register data about demographics, vascular risk factors, anticoagulation, mr, echocardiography and co-morbidity. with those variables associated with ich-oa in the univariate analyses, a regression analysis will be performed, in which ich-oa will be the dependent variable. finally, each independent predictive variable will receive a score to elaborate a predictive model of ich-oa.

Eligibility criteria:
inclusion criteria: 1. age \> 65 y 2. tia or ischemic stroke 3. the patient will receive indefinitely treatment with oral anticoagulants for the secondary prevention of cardioembolic stroke 4. no previous treatment with oral anticoagulants 5. signed consent before performing a magnetic resonance 6. long-term follow-up will be possible exclusion criteria: 1. the patient will receive oral anticoagulation as a primary prevention treatment 2. the etiology that motivates the onset of oral anticoagulants is not cardioembolism 3. absolute contraindication to receive oral anticoagulants 4. arterial hypertension that is not controlled, hypertensive crisis 5. dementia 6. live-expectancy less than 1 year 7. any social or psychological reason that prevents follow-up 8. contraindication to perform a magnetic resonance examination 9. patients who received oral antiacoagulants prior to the current stroke 10. the magnetic resonance imaging was performed more than 1 month after the onset of treatment with oral anticoagulants

Keywords: ischemic stroke intracerebral hemorrhage subdural hemorrhage microbleed leukoaraiosis oral anticoagulants
pharmacokinetics of polymyxin b in adult patients with cystic fibrosis

Conditions: Cystic Fibrosis; Polymyxin B

Summary: cystic fibrosis (cf) pulmonary disease is a major cause of morbidity and mortality in cf patients and is punctuated by episodes of acute exacerbation that require antibiotic treatment. pseudomonas aeruginosa is the predominant bacterial pathogen isolated in patients with acute exacerbations, and practice guidelines recommend combination antibiotics directed against this pathogen as initial therapy. such therapy traditionally consists of an antipseudomonal beta-lactam with either an antipseudomonal fluoroquinolone or an aminoglycoside. with growing p. aeruginosa multi-drug resistance, more adult patients present with isolates resistant to these traditional options. the polymyxins are a class of cyclic peptide antibiotics that exert bactericidal activity through binding to the lipopolysaccharide component of gram-negative bacterial membranes and include colistin and polymyxin b (pmb). in recent years, there is growing evidence of increased rates of acute kidney injury associated with colistin in critically ill patients. additionally, population pharmacokinetic (pk) studies suggest that fixed drug dosing may yield an improved therapeutic index over the traditional weight-based dosing of this agent. thus there is growing interest in use of pmb as an alternative in cf acute exacerbations but the optimal dosage regimen is not known. this is a single-center, open-label, non-interventional study to characterize the pharmacokinetics and safety of fixed-dose pmb in adult patients with cf by measuring serum concentrations in patients receiving iv therapy as a part of routine care. this study will help to validate existing population pk models and allow for adjustment of patient specific covariates (i.e. weight, renal function) unique to adult patients with cf. the study will also monitor for nephrotoxicity and neurotoxicity to determine if pmb has an acceptable margin of safety in this patient population. this investigation is the first to prospectively validate the pharmacokinetics and toxicities of fixed-dose pmb in cf and will guide optimal use of this compound in the management of acute pulmonary exacerbations.

this study initially planned to include "change in forced expiratory volume in one second (fev1)" and "non-response to therapy" as secondary outcome measures. these outcome measures were removed, as the small number of participants prohibited collection of significant data beyond what was collected for the baseline measures.

Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 years of age. 2. diagnosis of cf. 3. receiving polymyxin b in the course of routine care. exclusion criteria: 1. evidence of acute kidney injury during the 48 hours prior to and following initiation of pmb therapy. 2. extracorporeal organ support (including ecmo, ihd, and crrt). 3. pregnant or breastfeeding women.